Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Lab21 Among First to Offer FDA Approved Companion Diagnostic in the US

Published: Monday, July 16, 2012
Last Updated: Monday, July 16, 2012
Bookmark and Share
CLIA laboratory to provide guidance for the use of Erbitux®.

Lab21 Limited has announced that its CLIA laboratory in Greenville, South Carolina, has been named as one of nine laboratories in the US to offer the first FDA approved companion diagnostic test to provide guidance for the use of Erbitux® (cetuximab).

Recent FDA approval of the Qiagen therascreen KRAS test, allows it to be used to determine whether patients with metastatic colorectal cancer are suitable for treatment with Erbitux.

The test has been routinely used in Europe since 2008 and is the first KRAS assay to secure FDA approval.

The availability of this test gives healthcare providers an FDA approved test which provides fast, consistent and reliable data to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-targeted inhibitor therapy.

Lab21 has been providing a KRAS analysis service using the assay from its CPA Accredited laboratory in Cambridge, UK for both Amgen and Merck Serono since 2008, and has performed in excess of 6000 tests during this time, including patient samples originating in a number of countries in Europe and the Middle East.

Michael Bolick, President of Lab21 Inc., commented: “Lab21 Inc. is delighted to have launched the therascreen KRAS assay as part of our initial portfolio of molecular diagnostic tests. As the only laboratory in Qiagen’s launch group based in the South-eastern region of the US market, Lab21 is well positioned to be the first provider of this valuable service to the regional cancer community.”

Mike Annable, Divisional Director - Clinical Laboratory, added, “Lab21 has significant clinical experience with the therascreen KRAS assay having been one of the first commercial labs to provide this validated assay in the UK. We have been able to leverage this experience during the laboratory validation of the assay for the US market and we are pleased that Erbitux patients can benefit from this experience.”


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Lab21 Partners with Top 10 IVD Player
Agreement to develop, manufacture and distribute new Aspergillus molecular assay.
Wednesday, April 11, 2012
Lab21 Announces Appointment of Industry Expert Fraser Logue
Dr Logue joins Lab21 team as Group Director of Quality, Regulatory Affairs & Operations Excellence.
Tuesday, February 21, 2012
Scientific News
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
'Fountain of Youth' Protein Points to Possible Human Health Benefit
Patients with higher blood levels of growth factor have lower risk of cardiovascular problems.
Signature of Microbiomes Linked to Schizophrenia
Studying microbiomes in throat may help identify causes and treatments of brain disorder.
Imaging Software Could Speed Breast Cancer Diagnosis
Technology could improve access to diagnostic services in developing countries.
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Data Mining DNA For Polycystic Ovary Syndrome Genes
A new Northwestern Medicine genome-wide association study of PCOS – the first of its kind to focus on women of European ancestry – has provided important new insights into the underlying biology of the disorder.
Algorithm Interprets Breathing Difficulties to Aid in Medical Care
Researchers from North Carolina State University have developed an efficient algorithm that can interpret the wheezing of patients with breathing difficulties to give medical providers information about what’s happening in the lungs.
Researchers Develop qPCR Prognosis Test for NSCLC Patients
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the use of adjuvant therapy in patients struggling with the disease.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!